Spinal Cord Stimulation in the Treatment of Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-24

Study Completion Date

2017-04-25

Brief Summary

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Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking.

Spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. Experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in Parkinsons patients.

This exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of Parkinsons patients who are not adequately improved by drug therapy alone.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal cord stimulation

Group Type EXPERIMENTAL

spinal cord stimulation (St Jude Medical)

Intervention Type DEVICE

implantation of a spinal cord neurostimulation system : St Jude Medical Octrode 3183 (R) peridural lead connected to a St Jude Medical EonC (R) primary cell IPG

Interventions

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spinal cord stimulation (St Jude Medical)

implantation of a spinal cord neurostimulation system : St Jude Medical Octrode 3183 (R) peridural lead connected to a St Jude Medical EonC (R) primary cell IPG

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's disease since more than 5 years
* Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy

Exclusion Criteria

* Atypical Parkinson-like syndrome (e.g. progressive supranuclear palsy)
* Cognitive impairment (MMSE\<24)
* Psychiatric disease
* Contraindication of surgery
* Neuropathic pain in the lower limb or lumbar region

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No